Orelabrutinib plus standard immunochemotherapy with or without auto-HSCT for newly diagnosed DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 2 trial enrolling adults with newly diagnosed CD20-positive DLBCL. Participants receive four cycles of orelabrutinib combined with standard immunochemotherapy; transplant-eligible patients who achieve a response after cycle 4 may proceed to autologous stem cell transplantation, then receive maintenance orelabrutinib or not based on preference. Transplant-ineligible patients who respond after cycle 4 may receive 2–4 additional cycles of the combination therapy. The primary goal is to determine the 1-year progression-free survival with this approach. The study assesses feasibility, response depth, and tolerability within induction, potential transplant strategies, and maintenance timing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent;

  * Age 18-80 years at the time of signing informed consent, and willingness to comply with the study protocol procedures;

    * Pathologically confirmed CD20-positive DLBCL;

      ④ IPI score of 2-5;

      ⑤ ECOG performance status of 0-2;

      ⑥ Life expectancy ≥12 months;

      ⑦ Left ventricular ejection fraction (LVEF) ≥50% as assessed by multigated acquisition (MUGA) scan or echocardiography (ECHO);
      * Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or hypersplenism secondary to splenic involvement attributed to DLBCL as determined by the investigator; transfusion of blood products is permitted), defined as follows:

        1. Hemoglobin ≥90 g/L within 7 days prior to enrollment without packed red blood cell transfusion;
        2. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L;
        3. Platelet count ≥75 × 10⁹/L.

           ⑨ Adequate organ function.

           Exclusion Criteria:
* Presence of uncontrolled cardiovascular or cerebrovascular disease, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.;

  * Abnormal laboratory values at screening (unless attributable to lymphoma):

    1. Coagulation function: INR \> 1.5× the upper limit of normal (ULN); PT and APTT \> 1.5× ULN;
    2. Liver function: ALT or AST \> 2× ULN; ALP and bilirubin \> 1.5× ULN;
    3. Renal function: Creatinine \> 1.5× ULN; creatinine clearance \< 60 mL/min (estimated by the Cockcroft-Gault formula);

       ③ HIV-infected patients;

       ④ For HBsAg-positive patients, HBV DNA must be negative prior to enrollment. In addition, if a patient is HBsAg-negative but HBcAb-positive (regardless of HBsAb status), HBV DNA testing is still required. If the result is positive, antiviral therapy is needed, and HBV DNA must be negative prior to enrollment;

       ⑤ Requiring continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers. Patients who have taken strong or moderate CYP3A inhibitors or CYP3A inducers within 7 days prior to the first dose of study drug (or have not completed at least 5 half-lives since the last dose) are not eligible for enrollment;
       * Inability to swallow capsules or presence of gastrointestinal conditions that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction;

         * Other concurrent and uncontrolled medical conditions that, in the investigator's opinion, may affect the patient's participation in the study, including patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol.

Where it's running

• The Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Feng Zhu
• Email: frankfeng_2004@126.com
• Phone: 0516-85806985

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Hypofractionated Radiotherapy plus GM-CSF, Pomalidomide and Glofitamab for Newly Diagnosed PCNS-DLBCL

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• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

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• SCTB35 with Gemcitabine and Oxaliplatin in relapsed or refractory DLBCL

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• High-dose dexamethasone plus orelabrutinib versus placebo for newly diagnosed adult ITP

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.